Covidian Shiley Tracheostomy Tube Recall Issued After 3 Deaths

Covidien is recalling a number of tracheostomy tubes, used to help people breathe on ventilators, due to issues with the tubes leaking. The trach tube problem has resulted in at least 1,200 reported incidents, including at least three deaths. 

The FDA announced the tracheostomy tube recall on April 23, warning that the cuff of the tubes do not always hold in air as they should. If the cuffs leak, it could adversely affect ventilation, decreasing the amount of oxygen being received by patients. This could lead to serious injury or death under some circumstances.

Covidien sent a letter to customers (pdf) on April 13, alerting them that it had received reports of “serious adverse health consequences” due to problems with some versions of its cuffed Shiley tracheostomy tubes, as well as some custom and specialty tracheostomy tubes. Covidien has told FDA that it has received reports of at least three deaths and 1,200 incidents connected with the recalled trach tubes, according to FDA officials.

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In the affected units, the cuff does not hold air due to leaks in the pilot balloon inflation assembly. This can cause the ventilation system to lose the ability to create positive pressure in the airway, leading to a sudden decrease in the amount of oxygen being received by the patient, or a sudden increase in the amount of carbon dioxide in their blood.

The medical device recall affects 62 product codes and their associated lot numbers for Shiley Tracheostomy Products and Custom Shiley Tracheostomy Products, commonly referred to as “trach tubes”. All of the recalled devices were manufactured between November 2008 and December 2009. A complete list of the affected product codes and lot numbers is available in the FDA and Covidien press releases.

The FDA and Covidien are recommending that customers return any products affected by the recall. They can contact the company’s technical services department at 1-800-635-5267. Any healthcare professionals or patients who have experienced adverse events associated with this product should contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

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9 Comments

  • MirendaSeptember 14, 2011 at 6:33 pm

    my husband passed away June 7,2011. we are not sure what happened. they told us that when they have a trach as long as he has had it, it is possible to get blood poisioning... we were not aware of this. see comment by Toni on May 15,2010, i miss my best friendk, my husband of 40 yrs.

  • Linda C.April 30, 2011 at 5:46 pm

    My mother had a trachea, and on the day that she passed away she told my dad she couldn't breath. She passed away in the ambulance in the drive way. She had used to suction many times that morning. I have always believed that it was a defective trachea. Please help me find some peace.

  • MarkNovember 2, 2010 at 12:23 pm

    My father was in a hospital for 14 months before he died. He went in for cardiac bypass surgery. A Covidian tube was used, which was found to have a leak.This tube was in place for 1 week post operatively, before it was replaced.My father developed aspiration pneumonia during that time which led to him being unable to be weaned from the venilator, and this led to multiple organ failure. He never m[Show More]My father was in a hospital for 14 months before he died. He went in for cardiac bypass surgery. A Covidian tube was used, which was found to have a leak.This tube was in place for 1 week post operatively, before it was replaced.My father developed aspiration pneumonia during that time which led to him being unable to be weaned from the venilator, and this led to multiple organ failure. He never made it out of the hospital.

  • JohnJune 11, 2010 at 3:22 am

    As medical technologist I wish to share some opinion and information. While it is important to ensure that the pressures in cuffs are not underpowered be it for the tracheostomy tube or the endotracheal tube, it is equally important that pressures should be at optimal levels to maintain anchorage and prevent aspiration of subglottic residue into the lungs . Such residue is responsible for the ven[Show More]As medical technologist I wish to share some opinion and information. While it is important to ensure that the pressures in cuffs are not underpowered be it for the tracheostomy tube or the endotracheal tube, it is equally important that pressures should be at optimal levels to maintain anchorage and prevent aspiration of subglottic residue into the lungs . Such residue is responsible for the ventilator associated pneumonias which cost both health care service and patient outrageous amounts of money. Overpressurising the cuffs of the tubes mentioned earlier can lead to ischaemia , necrosis and stenosis . Stenosis may require very severe interventional procedures and as a result damage the quality of life of patients affected. It is timely to note also the other types of complications that patients could encounter or may have already encountered as a result of cuff pressures not being properly adminsterred . Sometimes the problem is elusive to the physician applying the tecnique of intubation or tracheostomy due to the defective instrumentation or device. In 2006 one of the endotracheal tubes was reported to the company as having been the subject of high suspiscion on the excessive pressures requireed to provide a seal within the trachea. Further this was reported to the FDA . How many patiens have sustained tracheal injury around the world is not known. Nevertheless the sequel to hyperpressured cuffs is serious [google "BJA Tracheal Surface Alterations] A defective cuff can contribute thus to varous levels of injury including death. It was reported in a learned journal by Anesthesiologists Magdalena and her colleagues [Anaesthesiology Intensive Therapy, 2009,XLI,4; 166-169] that edcessive cuff pressures may also lead to tracheal stenosis, formation of tracheo-oesophageal fistula or even life-threatening haemorrhage . Overinflation, she further reported , of the sealing cuff , may induce its herniation and thus result in airway obstruction. The most grave yet rare complication she reports is the rupture of the tracheal wall. A final point is that product managers of device manufacturers should declare the safety of the product before it is released into the market. Furthermore they should be protected when alerts are raised inhouse and when that fails they should be offered a higher level of protection when they blow the whistle and when the authorities are contacted. How unjustified it must be for managers and others who have stood up for protection of patients by reporting on device defects but were rebuffed or retaliated at by the companies they worked for ! Wongful dismissal in these circumstances must be mitigated from a commercial crime standpoint not merely as an industrial dispute.

  • BarryMay 30, 2010 at 7:21 pm

    As a nurse, working with homecare vents, leaking cuffs are a way of life since we started this in the mid 80's some trachs last for months some for weeks and sometimes are bad right away. we always travel with spare trachs in our bag. I was surprised to hear of this recall since this is what we have considered normal.

  • boboliMay 22, 2010 at 3:37 am

    My 10 year old daughter has a 4.5 pedi cuffed trach. It needs to be changed once a week sometimes sooner. The valve where you inject air with the syringe leaks. Some times so slowly that it is not noticed until she desaturates and has little pressure in her lungs. Sometimes she desats when the cuff is fully inflated. I did not know that was possible!!

  • ToniMay 15, 2010 at 1:59 pm

    My father has had a trach for several years now and the cuff has never held air the way it should. They also told my dad that it should only be changed every 3 months but seems like we are in to have it changed every 3wks to 1 1/2 months. I found this article, told my mom, and she notified the physican, but, i believe it is because I am a nurse that he would not respond. We have had problems in th[Show More]My father has had a trach for several years now and the cuff has never held air the way it should. They also told my dad that it should only be changed every 3 months but seems like we are in to have it changed every 3wks to 1 1/2 months. I found this article, told my mom, and she notified the physican, but, i believe it is because I am a nurse that he would not respond. We have had problems in the past with them putting the wrond size trach in dad at a previous visit which lead to surgery which did not correct the problem. He had to remain at the smaller trach. Now he is in the hospital and I am trying to get someone to read this article and take notice. His trach had to be changed again last night after only 3wks. His quality of life could have been improved with a better trach.

  • KendallMay 6, 2010 at 12:08 am

    The cuff of my son's tube would not stay inflated. He bled to death last week when the tube seemed to have ruptured a nearby blood vessel. I am having trouble figuring out if the defective cuff contributed to his death. I don't know the structure of these things well enough to know if the inflated cuff will also help the tube stay in place or at least keep the edge of the tube from rubbing agai[Show More]The cuff of my son's tube would not stay inflated. He bled to death last week when the tube seemed to have ruptured a nearby blood vessel. I am having trouble figuring out if the defective cuff contributed to his death. I don't know the structure of these things well enough to know if the inflated cuff will also help the tube stay in place or at least keep the edge of the tube from rubbing against his trachea. At the time of his death, we were pressured to forgo an autopsy and I am having trouble getting anyone to help me figure out if a defective trach tube has anything to do with his death..

  • LindaApril 28, 2010 at 5:31 am

    Fiance in past year has had this shiley pull apart at the flange, has had a pneumothorax from the collapse of inner cuff that obstructed his trach, which required a chest tube inserted. had 2 other episodes with inner cuff. The inner cuffs have tendency to get holes in them. I called company and was told the trach needs to be changed at least once every 21 days. However, his physician only want[Show More]Fiance in past year has had this shiley pull apart at the flange, has had a pneumothorax from the collapse of inner cuff that obstructed his trach, which required a chest tube inserted. had 2 other episodes with inner cuff. The inner cuffs have tendency to get holes in them. I called company and was told the trach needs to be changed at least once every 21 days. However, his physician only wants to do this once every 3-6 months. I have insisted now with Michael coming close to death, change trach monthy.

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